Label: SODIUM BICARBONATE ANTACID- sodium bicarbonate powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 24, 2017

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  • ACTIVE INGREDIENT

    Active ingredient (in each dose=1/2 teaspoon)        Purpose

    Sodium bicarbonate USP 2,616 mg ............................ Antacid

  • PURPOSE

    Purpose

    Antacid

  • INDICATIONS & USAGE

    Uses

    Relieves: 

    • heartburn
    • sour stomach
    • acid indigestion
    • upset stomach associated with these syptoms
  • WARNINGS

    Warnings

    FOR ORAL USE ONLY

    STOMACH WARNING: TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL POWDER IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FILL FROM FOOD OR DRINK.

    Do not use in children under 12 years of age.

    Ask a doctor or pharmacist before use if you have a sodium-restricted diet.

    Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    Stop use and ask a doctor if

    • you have used the maximum dosage for 2 wekks
    • sever stomach pain occurs after using this product
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • Take 1/2 teaspoon in 1/2 glass (4 fl. oz.) of water every 2 hours up to a maximum dosage or as directed by a doctor. Dissolve completely in water before drinking.
     Age Maximum Dosage
     Adults 60 years and overDo not exceed three doses of 1/2 teaspoon in a 24 hour period 
     Adults and children 12 years of age and overDo not exceed six doses of 1/2 teaspoon in a 24 hour period 
    Children under 12 years Do not use 

  • INACTIVE INGREDIENT

    Inactive Ingredients:

  • QUESTIONS

    Questions:

    1-800-560-5223 M-F 9AM to 4PM Eastern

    Menper Distributors Inc.

    www.menperdistributors.com

  • PRINCIPAL DISPLAY PANEL

    SodiumBic

  • INGREDIENTS AND APPEARANCE
    SODIUM BICARBONATE ANTACID 
    sodium bicarbonate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-390
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE2.616 g  in 2.616 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CATION (UNII: LYR4M0NH37)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-390-16454 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/2017
    2NDC:53145-390-08227 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/2017
    3NDC:53145-390-04113 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/01/2017
    Labeler - Menper Distributors Inc. (101947166)
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